Overview

TST001 in Patients With CLDN18.2 Positive Previously Treated Advanced Biliary Tract Cancer

Status:
Not yet recruiting
Trial end date:
2024-07-30
Target enrollment:
0
Participant gender:
All
Summary
TST001 is a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. This is an open-label, single-arm phase II study to evaluate the efficacy and safety of TST001 for patients with CLDN18.2 positive previously treated unresectable advanced or metastatic Biliary Tract Cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborator:
Transcenta Holding Limited
Criteria
Inclusion Criteria:

- Histologically confirmed, unresectable advanced or metastatic biliary tract cancer.

- Patients failed at least one prior line of systemic medications; if patients had
disease progression during or within 6 months after the completion of adjuvant therapy
or neoadjuvant therapy, the adjuvant therapy or neoadjuvant therapy could be regarded
as one line of therapy.

- CLDN18.2 expression positive confirmed through tumor tissue.

- Patients with at least one measurable disease according to RECISTv1.1.

- ECOG PS of 0 or 1.

- Patients have predicted life expectancy ≥ 12 weeks.

- Paitients with adequate cardica, liver, renal function, etc.

Exclusion Criteria:

- • History of another concurrent primary malignancy.

- Untreated or symptomatic CNS metastases.

- Prior treatment targeting CLDN18.2.

- Major surgical procedure, prior locoregional therapy such as radioembolization
within 28 days prior to the first dose of study drug.

- Prior serious hypersensitivity to monoclonal antibody or any component of the
investigational drug.

- Patients had any of the following within 6 months prior to first dose of study
treatment: cerebrovascular accident, transient ischemic attack, myocardial
infarction or unstable angina pectoris, heart failure NYHA III or IV degree, or
uncontolled uarrhythmia requiring intervention.

- Patients who are pregnant or lactating.